MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	21655200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Ear or Labyrinth Problem (4474); Ear Pain (4812); Ear infection (4813)
Date of Event	11/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.The device met specification before shipment.Clinical evaluation of the event: it has been reported that user experienced pain, redness, swelling and wetness at external auditory meatus on one side.Symptoms are described as being present only on one side but both right and left side has been mentioned.User has the same device and receiver configuration of the other side without issue.The user was fit with earmold on (b)(6) 2023.Symptoms with the ear began on saturday on (b)(6) 2023 and reported laryngitis onset on (b)(6) 2023.User went to urgent care on (b)(6) 2023 to address concerns with the ear.No swab was done in the ear but pt reported that her nose and throat were swabbed and was negative for both bacteria and fungi.User was prescribed a 10-day course of amoxicillin 2/day am and pm for an ear infection.Per the patient there was no clarification on whether it was otitis externa or otitis media.The patient self-treated the reported redness and swelling with benadryl and hearing aid rest on the side of concern.She reported relief but it is unclear on whether the relief was experienced in conjunction with the onset of her prescribed medication.When the hearing care professional saw the user, she was presenting healthily and thus no pictures of the reaction was taken.This is an experienced user who has worn hearing aids for at least 25 years who has never experienced this issue before.User reportedly has a history of sudden hearing loss over 20 years ago after an unspecified ear infection.It is reported that user has an allergy to surgical glue and she, post cancer treatment, is concerned that the glue on the earmold was similar in content.No further information on the cancer or its treatment has been provided.Based on available information, it is inconclusive that the reaction is caused by wearing the hearing aid.It is unlikely that these symptoms will lead to a serious injury or permanent damage as the symptoms are not present anymore.Earmolds may be made of acrylic or soft silicone material.As earmolds are designed to have skin contact, the material used is biocompatible and a biological evaluated according to procedure.Hearing aids are typically being worn many hours per day and it is not uncommon that the skin contact can cause minor skin irritation.However, many users get accustomed to the material and the itching or irritation.In rare cases, an allergic reaction to the earmolds can develop.In some cases, treatment with topical steroid and/or antibiotics will be necessary to stop the skin irritation.A temporary pause in the hearing aid use, or modification to the earmold shape by the hearing care professional, is also recommended to help the healing process.The user guide includes a caution to consult the hearing care professional if irritation should occur.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Risk register conclusion reference: the precise nature and cause of the issue described is not definitive, however it falls within already known risks associated with the use of the device which are considered to be acceptable.Manufacturer's investigation is final.This is a combined (initial and final) report.No further information is provided and is expected.
Event or Problem Description
Date of incident: (b)(6) 2023 it was reported that the user experiences pain and swelling on one side, in the external ear canal.Symotoms reported were red, swollen, painful.Reported that with removal of the device improved issue.But also reported that the issue started after a bout of laryngitis.Fit with earmold on (b)(6) 2023 symptoms with the ear began on saturday on (b)(6) 2023 reported laryngitis onset on (b)(6) 2023 user is reportably allergic to surgical glue.The user was seen in urgent care to address concerns with the ear, and was prescribed amoxicillin a 10-day course 2/day am and pm.No further follow up has been received and is expected.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 18491010
• Report Number: 3005650109-2024-00004
• Device Sequence Number: 3690514
• Product Code: OSM
• UDI-Device Identifier: 05708296213375
• UDI-Public: 05708296213375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 21655200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female